星点设计-效应面法优化三维打印片处方
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摘要
目的:采用星点设计-效应面优化法优选三维打印的华法林钠口崩片处方。方法:以片剂的硬度(Y_1)和崩解时间(Y_2)为考察指标,以蔗糖与预胶化淀粉质量比例(X_1)、聚维酮与微晶纤维素质量比例(X_2)、乙醇浓度(X3,%)为考察项,采用星点设计-效应面法预测较优处方并进行验证。结果:确定其最优处方为蔗糖与预胶化淀粉质量比例(X_1)为0.92、聚维酮与微晶纤维素质量比例(X_2)为1.05、乙醇浓度(X_3,%)为37.75,实测值与预测值的最终差异显示无统计学意义。结论:所选制备处方较为合理,星点设计-效应面法可用于三维打印华法林钠口崩片的处方优化。
Objective: To optimize the formulation of oral disintegrating tablets of warfarin sodium produced by 3D printing. Methods: Central composite disign-response surface method was used to predict and validate the optimal formulation with the hardness of the tablet( Y_1) and disintegration time( Y_2) as indexes,using sucrose/pregelatinized starch ratio( X_1),povidone/microcrystalline cellulose ratio( X_2) and ethanol concentration( X_3,%) as investigation factors. Results: The optimal formulation was determined and its sucrose/pregelatinized starch ratio( X_1) was 0. 92,povidone/microcrystalline cellulose ratio( X_2) was 1. 05,and the ethanol concentration( X_3,%) was 37. 75. There was no statistically significant difference between the measured and precidicted values. Conclusion: The selected formulation is reasonable and central composite disign-response surface method is suitable for the formulation optimization of oral disintegrating tablets of warfarin sodium produced by 3D printing.
Objective: To optimize the formulation of oral disintegrating tablets of warfarin sodium produced by 3D printing. Methods: Central composite disign-response surface method was used to predict and validate the optimal formulation with the hardness of the tablet( Y_1) and disintegration time( Y_2) as indexes,using sucrose/pregelatinized starch ratio( X_1),povidone/microcrystalline cellulose ratio( X_2) and ethanol concentration( X_3,%) as investigation factors. Results: The optimal formulation was determined and its sucrose/pregelatinized starch ratio( X_1) was 0. 92,povidone/microcrystalline cellulose ratio( X_2) was 1. 05,and the ethanol concentration( X_3,%) was 37. 75. There was no statistically significant difference between the measured and precidicted values. Conclusion: The selected formulation is reasonable and central composite disign-response surface method is suitable for the formulation optimization of oral disintegrating tablets of warfarin sodium produced by 3D printing.
引文
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[10]赖滢滢,王岩,张英丰.星点设计-效应面法进行蛇床子素脂质体处方优化的研究[J].中国新药杂志,2015,24(6):708-712.
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[12]别海燕,王宏丽,王英婷.星点设计-响应面法优化盐酸氮卓斯汀温敏型原位凝胶滴眼液处方[J].中国新药杂志,2016,25(8):954-960.
[13]王子臣,赵文明.星点设计-效应面法优化制备吉非替尼壳聚糖鱼精蛋白纳米粒[J].中国新药杂志,2016,25(7):807-812,822.
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[2]刘珍,孙明杰.首款3D打印抗癫痫药物——Spritam[J].药学研究,2015,34(9):556-558.
[3]林启凤,田盼,陈燕忠,等.3D打印速效救心口崩片的制备研究[J].广东药学院学报,2016,32(1):1-4.
[4]卢振华,洪李锋,罗松辉,等.新型口服抗凝药时代华法林的应用[J].临床心血管病杂志,2016,32(11):1083-1086.
[5]方小爱,谢清春,吕竹芬,等.Box-Behnken响应面法优化乌榄叶中酚类成分的提取工艺研究[J].广东药科大学学报,2017,33(2):167-171.
[6]石庆平,张志涛,丁峰,等.星点设计-效应面法优化薯蓣总皂苷口腔崩解片处方[J].中成药,2014,36(12):2508-2512.
[7]李晓娟,郭亚可,韩博,等.星点设计-效应面法优化壳聚糖温敏凝胶的制备及缓释性考察[J].中国新药杂志,2014,23(7):824-828.
[8]国家药典委员会.中华人民共和国药典[S].2015年版.四部.北京:中国医药科技出版社,2015:119.
[9]顾永卫,姜琳莉,杨盟,等.星点设计-效应面法优化盐酸普萘洛尔凝胶的处方及透皮吸收研究[J].中国新药杂志,2017,26(15):1827-1831.
[10]赖滢滢,王岩,张英丰.星点设计-效应面法进行蛇床子素脂质体处方优化的研究[J].中国新药杂志,2015,24(6):708-712.
[11]马薇,吕竹芬,陈燕忠.星点设计-效应面法优化普仑司特自微乳给药系统[J].中国新药杂志,2016,25(10):1153-1159.
[12]别海燕,王宏丽,王英婷.星点设计-响应面法优化盐酸氮卓斯汀温敏型原位凝胶滴眼液处方[J].中国新药杂志,2016,25(8):954-960.
[13]王子臣,赵文明.星点设计-效应面法优化制备吉非替尼壳聚糖鱼精蛋白纳米粒[J].中国新药杂志,2016,25(7):807-812,822.
[14]国家药典委员会.中华人民共和国药典[S].2015年版.二部.北京:中国医药科技出版社,2015:375.